Cleared Traditional

K190131 - AcQMap High Resolution Imaging and Mapp...

K190131 is the FDA 510(k) clearance for AcQMap High Resolution Imaging and Mapp... by Acutus Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K190131 · Acutus Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
64d
Days
Class 2
Risk

K190131 is an FDA 510(k) clearance for the AcQMap High Resolution Imaging and Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 2, 2019 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acutus Medical, Inc. devices

Submission Details

510(k) Number K190131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2019
Decision Date April 02, 2019
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 246
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K190131.
Intra-Operative Positioning System
K190106 · Centerline Biomedical, Inc. · Jun 2019
VIVO
K183195 · Catheter Precision, Inc. · Jun 2019
Edwards Pressure Cable
K191089 · Edwards Lifesciences, LLC · Jun 2019
KardiaAI
K181823 · AliveCor, Inc. · Mar 2019
RhythmAnalytics
K182344 · Biofourmis Singapore Pte., Ltd. · Mar 2019
EP-TRACER System
K183266 · Schwarzer Cardiotek GmbH · Mar 2019